Enlivex Ltd. · NASDAQ:ENLV
Enlivex — Investor Presentation (November 2025)
30 slides from Enlivex's investor presentation, November 2025
Slide 1: Enlivex Clinical Development
ENLIVEX CLINICAL DEVELOPMENT November 2025 Nasdaq: ENLV
Slide 2: Forward-Looking Statements
FORWARD-LOOKING STATEMENTS These slides and the accompanying oral presentation contain forward- looking and (vii) our expectations regarding our ability to obtain and maintain intellectual statements and information. Forward-looking statements are subject to known and property protection for our pro
Slide 3: Macrophage Modulation for the Treatment of Inflammatory Diseases
MACROPHAGE MODULATION FOR THE TREATMENT OF INFLAMMATORY DISEASES Enlivex is a clinical stage pharmaceutical company developing Allocetra , a universal, off-the-shelf cell therapy designed to reprogram macrophages into their homeostatic state, for treatment of inflammatory diseases. About: ON A A All
Slide 4: Cellular First Responders: Macrophages and Their Critical Role in Inflammation
CELLULAR FIRST RESPONDERS: MACROPHAGES AND THEIR CRITICAL ROLE IN INFLAMMATION Macrophages, which are found in abundance throughout the Macrophages orchestrate inflammation and its resolution. body, are immune cells that reside in or infiltrate human tissue. Main functions: Role in inflammation: 1 I
Slide 5: Promoting Balance: Apoptotic Cells Facilitate Macrophage Homeostasis
PROMOTING BALANCE: APOPTOTIC CELLS FACILITATE MACROPHAGE HOMEOSTASIS Prof. Dror Mevorach How apoptotic cells Scientific Founder influence macrophages Eat Apoptotic Cells Induce NF-kB and PtdSer me TAM Inflammasome Negative Signaling Amir Grau, Adi Tabib, Inna Grau, Inna Enlivex's Allocetra mechanism
Slide 6: Allocetra: An Off the Shelf Cell Therapy Designed to Restore Macrophage Homeostasis
ALLOCETRA : AN OFF THE SHELF CELL THERAPY DESIGNED TO RESTORE MACROPHAGE HOMEOSTASIS Process: A A PtdSer A Eat me A A A A Apoptotic cell collect cells from proprietary cells express cells are off the shelf, healthy donors apoptotic cell “eat me” signal frozen cost effective cell modification process
Slide 7: Allocetra Current Pipeline: Building Momentum
TM ALLOCETRA CURRENT PIPELINE: BUILDING MOMENTUM Indication Study # Administration Pre-clinical Phase I/II Phase II Phase III Moderate to severe Local knee Randomized/controlled, Expected initiation ENX-CL-05-001 injection knee osteoarthritis NCT06233474 149 patients, enrollment completed Q2 2026 Te
Slide 8: Allocetra for the Treatment of Osteoarthritis
ALLOCETRA FOR THE TREATMENT OF OSTEOARTHRITIS 8 | Nasdaq: ENLV
Slide 9: Osteoarthritis: A Growing Market with Significant Potential
OSTEOARTHRITIS: A GROWING MARKET WITH SIGNIFICANT POTENTIAL Disease overview Market Standard of care U.S. Cases1: Femur Today 2040 Lifestyle changes Joint space Subchondral narrowing bone cysts/ sclerosis 32.5MM 78MM Synovitis Physiotherapy Cartilage loss Market size2: Fibula Tibia 2023 2030 Pain me
Slide 10: Macrophages Are an Emerging New Target for Osteoarthritis Treatment
MACROPHAGES ARE AN EMERGING NEW TARGET FOR OSTEOARTHRITIS TREATMENT The role of innate immunity Imbalance of M1/M2 macrophages is linked in osteoarthritis: when our first line of defense to severity level of knee osteoarthritis. goes on the offensive. Baolong Liu, Maoquan Zhang, Jingming Zhao, Eric
Slide 11: Knee Osteoarthritis (KOA) Market
KNEE OSTEOARTHRITIS (KOA) MARKET • High prevalence & burden: Prevalence of Osteoarthritis increases with age1 • 32M Americans today; projected 78M by 2040 60 • One of the most disabling diseases globally 50 • Unmet medical need: Prevalence (%) • No approved disease-modifying treatments 40 • Current
Slide 12: Results from the Completed ENX-CL-05-001 Phase IIa in Knee OA
RESULTS FROM THE COMPLETED ENX-CL-05-001 – PHASE IIa IN PATIENTS WITH SYMPTOMATIC MODERATE TO SEVERE KNEE OA 12 |
Slide 13: ENX-CL-05-001 Phase IIa Study Designed A Priori to Identify Correlation of Treatment Effect
ENX-CL-05-001 – PHASE IIa STUDY DESIGNED A PRIORI TO IDENTIFY CORRELATION OF TREATMENT EFFECT AND BASELINE FACTORS Inflammation Heterogeneous patient population OA leading experts forewarned included indiscriminately us prior to study design Purpose was to assess safety, efficacy, and potentially fi
Slide 14: Phase IIa Objectives Met: Safety, Positive Effect, High Responders Identified
ENX-CL-05-001 – PHASE IIa OBJECTIVES MET: (a) FAVORABLE SAFETY PROFILE & POSITIVE EFFECT, (b) HIGH RESPONDERS WERE IDENTIFIED (REPRESENTING 50% OF THE KOA MARKET) • We had clear success in isolating the key molecular disease for which our drug works well • This finding directly illustrates that our
Slide 15: Knee Osteoarthritis Phase IIa Results - 3 & 6-Month Topline Data Analysis
ENX-CL-05-001 KNEE-OSTEOARTHRITIS PHASE IIa RESULTS - 3 & 6-MONTH TOPLINE DATA ANALYSIS 15 |
Slide 16: ENX-CL-05-001: Phase I/IIa 2-Stage Trial Design
ENX-CL-05-001: PHASE I/IIa 2-stage trial design - randomized, double-blind, placebo-controlled, multi-country study Patient criteria Phase I: Dose escalation & safety • Patients with symptomatic 15 patients moderate to severe knee OA who have failed Independent safety committee→ no negative safety s
Slide 17: Competitive Comparison of Standardized Effect Sizes
COMPETITIVE COMPARISON OF STANDARDIZED EFFECT SIZES 1.2 AllocetraTM 1.1 Standardized Effect Size 1.0 Efficacy Endpoint mITT ≥60 ≥65 NRS Pain Change from Baseline (scale 0-10) 0.9 3 Months -0.22 -0.41 -0.76 0.8 6 Months -0.08 -0.30 -0.80 WOMAC (Function) WOMAC Pain Change from Baseline (randomized 0-
Slide 18: Pain NRS Weekly Change Over Time
PAIN NRS WEEKLY CHANGE OVER TIME Substantial and durable weekly pain NRS reduction compared to placebo, with increased effect trending with age. Placebo Allocetra 18 |
Slide 19: Responder Rates (OMERACT-OARSI Criteria) - WOMAC Pain
RESPONDER RATES (OMERACT-OARSI CRITERIA) – WOMAC PAIN High responder rates compared to placebo, with increasing percentages trending with age Age threshold 3m 6m ≥ 60 Placebo 50% 58% Trending with age Allocetra 71% 65% % better than placebo 41% 12% p-value 0.0773 0.5604 ≥ 63 Placebo 37% 44% Allocetr
Slide 20: Allocetra Effect in Primary OA: Reduction in Pain, 3 Months
ALLOCETRA EFFECT IN PRIMARY OA: CLINICALLY MEANINGFUL, STATISTICALLY SIGNIFICANT, TRENDING WITH AGE (REDUCTION IN PAIN) WOMAC pain change 3 months, Primary OA population Age ≥ 60 (54% of patients) Age ≥ 63 (40% of patients) Age ≥ 65 (33% of patients) WOMAC pain change, 3 months Allocetra Placebo All
Slide 21: Allocetra Effect in Primary OA: Reduction in Pain, 6 Months
ALLOCETRA EFFECT IN PRIMARY OA: CLINICALLY MEANINGFUL, STATISTICALLY SIGNIFICANT, TRENDING WITH AGE (REDUCTION IN PAIN) WOMAC pain change 6 months, Primary OA population Age ≥ 60 (52% of patients) Age ≥ 63 (39% of patients) Age ≥ 65 (31% of patients) WOMAC pain change, 6 months Allocetra Placebo All
Slide 22: Allocetra Effect in Primary OA: WOMAC Total, 3 Months
ALLOCETRA EFFECT IN PRIMARY OA: CLINICALLY MEANINGFUL, STATISTICALLY SIGNIFICANT, TRENDING WITH AGE (REDUCTION IN PAIN & STIFFNESS, AND INCREASE IN FUNCTION) WOMAC total change 3 months, Primary OA population Age ≥ 60 (54% of patients) Age ≥ 63 (40% of patients) Age ≥ 65 (33% of patients) WOMAC pain
Slide 23: Allocetra Effect in Primary OA: WOMAC Total, 6 Months
ALLOCETRA EFFECT IN PRIMARY OA: CLINICALLY MEANINGFUL, STATISTICALLY SIGNIFICANT, TRENDING WITH AGE (REDUCTION IN PAIN & STIFFNESS, AND INCREASE IN FUNCTION) WOMAC total change 6 months, Primary OA population Age ≥ 60 (52% of patients) Age ≥ 63 (39% of patients) Age ≥ 65 (31% of patients) WOMAC pain
Slide 24: Clinically Meaningful, Statistically Significant Positive Effect Correlated with Age Threshold
CLINICALLY MEANINGFUL, STATISTICALLY SIGNIFICANT POSITIVE EFFECT, HIGHLY CORRELATED WITH PRIMARY OA AGE THRESHOLD The positive effect of AllocetraTM on pain & function is substantial, with at least 6-month durability Change from baseline - 3 months Change from baseline - 6 months Trending with age A
Slide 25: Safety Profile: Favorable, No Related Serious Adverse Events
SAFETY PROFILE: ALLOCETRATM DEMONSTRATED A FAVORABLE SAFETY PROFILE, NO RELATED SERIOUS ADVERSE EVENTS WERE REPORTED • As observed also in earlier clinical data in severe OA subjects, some patients injected with Allocetra experienced local responses following injection (84% of patients treated with
Slide 26: Data Summary: 3 and 6-Month Topline Data - ENX-CL-05-001
DATA SUMMARY: 3 AND 6-MONTH TOPLINE DATA – ENX-CL-05-001 • Study objectives met • AllocetraTM demonstrated an encouraging safety profile, no related serious adverse events were reported • In primary age-related osteoarthritis patients, AllocetraTM treatment resulted in substantial, clinically meanin
Slide 27: Next Step: Initiate ENX-CL-05-002, a Phase IIb in Primary KOA Patients
NEXT STEP: INITIATE ENX-CL-05-002, a PHASE IIb in primary KOA patients Randomized, double-blind, placebo-controlled, multi-country study Phase IIb: Randomized, double-blind, placebo-controlled Patient criteria AllocetraTM (1 or 2 doses) vs. Placebo , 3 injections in total, • Primary OA patients with
Slide 28: Extensive IP Protection
EXTENSIVE IP PROTECTION Australia Canada China Expected protection up to 11 Patents USA 22 Patents France Germany 2043 Israel Japan United Kingdom 28 | Nasdaq: ENLV
Slide 29: Clinical Investment Summary
CLINICAL INVESTMENT SUMMARY Management team with a track record of creating shareholder value and getting drug products through marketing approvals globally in multi-billion dollar market segments Cost-effective, novel therapeutic modality with strong IP protection Targeted at high and low grade inf
Slide 30: Thank You
THANK YOU